A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Behavior; Glucagon-Like Peptide-1 Receptor; Feeding Behavior; Metabolic Disorders; Diabetes Mellitus, Type 2; Endocrine System Diseases; Glucagon-Like Peptide Receptors; Membrane Proteins; Receptors, Cell Surface; Diabetes Melletus; Glucose Metabolism Disorders; Proteins; Receptors, G-Protein-Coupled; Receptors, Peptide; Fasting; Nutritional and Metabolic Diseases

Treatments: Drug: Orforglipron

Study type: Interventional

Funder types: Industry

Identifiers

NCT07613307

27746

J2A-MC-GZPV (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.
• Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol/mol)) to less than 9.5% (91 mmol/mol) at screening.
• Intend to be compliant with the fast during the Ramadan period.
• Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.
• Have body mass index (BMI) of 25 kilograms per meter square (kg/m2) or higher at screening.

Exclusion criteria

• Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes
• Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Have a history of chronic or acute pancreatitis any time prior to screening
• Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
• Have a history of cholecystectomy (surgically removed gallbladder)
• Have New York Heart Association Functional Classification IV congestive heart-failure.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Orforglipron

Experimental group

Description:

Administered orally

Treatment:

Drug: Orforglipron